Product code GKA
- Device name
- Abnormal Hemoglobin Quantitation
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7415
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | 2024-04-04 |
| K222635 | Premier Resolution System | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | 2023-08-04 |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | Helena Laboratories, Corp. | 2022-04-19 |
| K180762 | CAPI 3 HEMOGLOBIN(E) | Sebia | 2018-12-14 |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | Bio-Rad Laboratories, Inc. | 2017-09-13 |
| K112550 | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM | Sebia | 2012-05-25 |
| K112491 | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 | Sebia | 2012-05-24 |
| K091283 | CAPILLARYS NEONAT HB (PN 2006) | Sebia | 2010-02-22 |
| K082227 | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 | Sebia | 2009-03-26 |
| K080911 | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2008-05-02 |
| K052291 | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) | Sebia | 2006-06-27 |
| K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | Wallac OY | 2006-03-08 |
| K051072 | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM | Bio-Rad Laboratories, Inc. | 2005-05-12 |
| K040146 | INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | 2004-05-04 |
| K955355 | VARIANT ALPHA-THALASSEMIA SHORT PROGRAM | Bio-Rad | 1996-04-26 |
| K955283 | PRIMUS VARIANT SYSTEM PVS99 | Primus Corp. | 1996-03-01 |
| K954048 | VARIANT HEMOGLOBINOPATHY PROGRAM | Bio-Rad | 1995-11-20 |
| K924813 | VARIANT SICKLE CELL SHORT PROGRAM | Bio-Rad | 1993-01-14 |
| K834595 | PARAGON ACID HEMOGLOBIN REAGENT KIT | Beckman Instruments, Inc. | 1984-05-07 |
| K840011 | RESOLVE-HB | Isolab, Inc. | 1984-02-04 |
| K822123 | ISOPROPANOL HEMOGLOBIN STABILITY TEST | Helena Laboratories | 1982-08-05 |
| K820573 | HELENA HEMOGLOBIN DETECT COLUMN SYS | Helena Laboratories | 1982-04-01 |
| K811894 | ORTHO SICKLE CELL CONTROLS | Ortho Diagnostic Systems, Inc. | 1981-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03607360012444 | CAPILLARYS 3 DBS | SEBIA | 2024-04-30 |
| 03607360025062 | CAPI 3 NEONAT Hb | SEBIA | 2024-04-30 |
| 03607360025635 | CAPI 3 NEONAT HEMOLYSING SOLUTION | SEBIA | 2024-04-30 |
| 03607360025789 | CAPILLARYS 3 DBS MICROPLATES | SEBIA | 2024-04-30 |
| 00847817000560 | VARIANT nbs Newborn Screening | BIO-RAD LABORATORIES, INC. | 2023-01-31 |
| 00847817007187 | Hemoglobin Variants System | BIO-RAD LABORATORIES, INC. | 2020-06-24 |
| 00847817007057 | Hemoglobin Variants System | BIO-RAD LABORATORIES, INC. | 2020-06-24 |
| 00847817007064 | Hemoglobin Variants System | BIO-RAD LABORATORIES, INC. | 2020-06-24 |
| 00847817007071 | Hemoglobin Variants System | BIO-RAD LABORATORIES, INC. | 2020-06-24 |
| 00847817007156 | Hemoglobin Variants System | BIO-RAD LABORATORIES, INC. | 2020-06-24 |
| 00847817007170 | Hemoglobin Variants System | BIO-RAD LABORATORIES, INC. | 2020-06-24 |
| 03607360020074 | CAPILLARYS HEMOGLOBIN | SEBIA | 2018-01-24 |
| 03607360022078 | MINICAP HEMOGLOBIN | SEBIA | 2018-01-24 |
| 05391516744119 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-20 |
| 05391516744102 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-20 |
| 05391516748179 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-20 |
| 05391516748186 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-20 |
| M52551270 | Hemolysate Reagent | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551280 | Hemolysate Reagent | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551250 | Hemolysate Reagent | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| 05391516744195 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516744201 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516744232 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516744249 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516744256 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516744263 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516744522 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516744539 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 05391516748193 | Trinity Biotech | PRIMUS CORPORATION | 2016-09-06 |
| 06438147000784 | RESOLVE Systems Hemoglobin Kit | Wallac Oy | 2016-02-02 |